A Study To Estimate The Relative Bioavailability Of PF-00258210 Administered Alone Or In Combination With PF-00610355

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01043276
First received: December 7, 2009
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

The purpose of this study if to investiagte the time course of PF-00258210 plasma concentration in the presence or absence of PF-00610335 administered via oral inhalation using dry powder inhalers


Condition Intervention Phase
Asthma
Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Drug: Treatment D
Drug: Treatment E
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single Dose, Open, Randomized, 5-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of PF-00258210 Administered Alone Or PF-00258210 Administered Together With PF-00610355 Either As A Free Or A Fixed Dose Combination

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • plasma pharmacokinetics AUClast and Cmax [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma pharmacokinetics, AUCinf and Tmax [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Treatment A
PF-00258210 220 µg using inhaler A
Experimental: Treatment B Drug: Treatment B
PF-00258210 220 µg using inhaler A and 450 µg PF-00610335 using inhaler A
Experimental: Treatment C Drug: Treatment C
PF-00258210 440 µg and 450 µg PF-00610335 using inhaler A
Experimental: Treatment D Drug: Treatment D
PF-00258210 350 µg and 450 µg PF-00610335 using inhaler A
Experimental: Treatment E Drug: Treatment E
PF-00258210 220 µg using inhaler B

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • A positive urine drug screen
  • Pregnant or nursing females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043276

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01043276     History of Changes
Other Study ID Numbers: B0751001
Study First Received: December 7, 2009
Last Updated: April 26, 2010
Health Authority: Singapore: Health Authority and EC

Keywords provided by Pfizer:
Healthy

ClinicalTrials.gov processed this record on September 16, 2014